Clinical trial Recruiting at 43 sites Observational Ages 18 and up

Registry for optimal treatment options for mitral valve issues

Official title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

Run by Universitätsklinikum Hamburg-Eppendorf · NCT04688190 · Data updated 2026-11-12

This study looks at how well different treatments work for people with serious mitral valve problems, comparing those who had a new valve implanted to those who weren't able to get that treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorUniversitätsklinikum Hamburg-Eppendorf
Academic / other
Locations43 sites (Tucson, Arizona and 42 other locations)
StatusRecruiting
StartedNovember 1, 2020
Main results expectedDecember 1, 2030
Study endsDecember 31, 2030
Registry record updatedMay 7, 2026
Trial IDNCT04688190 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults with clinically significant mitral insufficiency who have been screened for TMVI.

Probably not a fit

Patients under 18 years of age will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multinational observational study investigates the outcomes of patients with clinically significant mitral insufficiency who underwent transcatheter mitral valve implantation (TMVI) compared to those who were screened for TMVI but deemed ineligible. The study collects and analyzes echocardiography data at baseline and after various interventions, including edge-to-edge repair and surgical options. By examining these outcomes, the study aims to provide insights into the effectiveness of different treatment approaches for mitral regurgitation.

Why it matters

Potential benefit: If successful, this study could help identify the most effective treatment options for patients with mitral regurgitation, leading to improved patient outcomes.

How similar studies have gone: Other studies have shown success with similar observational approaches in evaluating treatment outcomes for heart conditions, suggesting this methodology is promising.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* clinically significant mitral insufficiency
* patient underwent screening for TMVI
* echocardiography data at baseline (and after TMVI, E2E and surgery)
* follow-up of at least 30 days

Exclusion Criteria:

\- age under 18 years

Where it's running

  • Tucson Medical Center
    Tucson, Arizona, United States
    Recruiting
  • Cedars-Sinai Medical Center, Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Tampa General Hospital
    Tampa, Florida, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Minneapolis Heart Institute at Abbott Northwestern Hospital
    Minneapolis, Minnesota, United States
    Recruiting
  • Morristown Medical Center
    Morristown, New Jersey, United States
    Recruiting
Show 37 more locations
  • Montefiore Medical Center
    New York, New York, United States
    Recruiting
  • Oklahoma Heart Hospital
    Oklahoma City, Oklahoma, United States
    Recruiting
  • Houston Methodist Hospital
    Houston, Texas, United States
    Recruiting
  • St Vincent's Hospital
    Sydney, Australia
    Recruiting
  • Medical University of Vienna
    Vienna, Austria
    Recruiting
  • Québec Heart and Lung Institute (Laval University)
    Québec, Quebec, Canada
    Recruiting
  • Toronto Heart Center
    Toronto, Canada
    Recruiting
  • St. Paul's Hospital
    Vancouver, Canada
    Recruiting
  • Rigshospitalet
    Copenhagen, Denmark
    Recruiting
  • CHU Bordeaux
    Bourdeaux, France
    Recruiting
  • Lille University Hospital
    Lille, France
    Recruiting
  • Civils Hospices of Lyon
    Lyon, France
    Recruiting
  • Clinique Pasteur
    Toulouse, France
    Recruiting
  • HDZ Bad Oeynhausen
    Bad Oeynhausen, Germany
    Recruiting
  • German Heart Center Berlin
    Berlin, Germany
    Recruiting
  • Heart Center Bonn
    Bonn, Germany
    Recruiting
  • University Hospital of Cologne
    Cologne, Germany
    Recruiting
  • Goethe-Universität - University Hospital Frankfurt
    Frankfurt, Germany
    Recruiting
  • University Heart and Vascular Center Hamburg
    Hamburg, Germany
    Recruiting
  • University Heart Center Lübeck
    Lübeck, Germany
    Recruiting
  • Heart Center of the University Medical Center Mainz
    Mainz, Germany
    Recruiting
  • German Heart Centre Munich
    Munich, Germany
    Recruiting
  • LMU Munich
    Munich, Germany
    Recruiting
  • University Medical Center Ulm
    Ulm, Germany
    Recruiting
  • Interbalkan Medical Center
    Thessaloniki, Greece
    Recruiting
  • ASST Spedali Civili di Brescia
    Brescia, Italy
    Recruiting
  • San Raffaele University Hospital
    Milan, Italy
    Recruiting
  • IRCCS Humanitas Research Hospital
    Milan, Italy
    Recruiting
  • IRCCS Policlinico San Donato
    Milan, Italy
    Recruiting
  • University Hospital of Pisa
    Pisa, Italy
    Recruiting
  • Rikshospitalet, Oslo University Hospital (OUS)
    Oslo, Norway
    Recruiting
  • Poznan University of Medical Sciences
    Poznan, Poland
    Recruiting
  • Warsaw Medicover Hospital
    Warsaw, Poland
    Recruiting
  • Inselspital Bern
    Bern, Switzerland
    Recruiting
  • USZ Zurich
    Zurich, Switzerland
    Recruiting
  • Royal Brompton Hospital
    London, United Kingdom
    Recruiting
  • St Thomas' Hospital - London
    London, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Lenard Conradi, MD — University of Cologne
  • Study coordinator: Sebastian Ludwig, MD
  • Email: se.ludwig@uke.de
  • Phone: +494074100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • MITRAL II Pivotal: Transcatheter mitral valve replacement for severe mitral annular calcification

    This trial tests whether placing an Edwards SAPIEN transcatheter valve through a transseptal approach helps high-surgical-risk adults with severe mitral annular calcification and symptomatic mitral valve dysfunction.

    Recruiting at 14 sites Mayo Clinic · Gilbert, Arizona and 16 other locations · NCT04408430

  • Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering

    This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.

    Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07612553

  • Surgical implantation of a polymer prosthetic mitral or aortic valve

    This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

    Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

  • Abbott Cephea registry for mitral valve disease

    Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.

    Recruiting at 24 sites Abbott Medical Devices · Birmingham, Alabama and 23 other locations · NCT07069673

  • Left atrial shunt to help after mitral valve surgery

    This study tests whether making a small opening between the left and right atria during mitral valve repair can relieve high left atrial pressure for adults with primary mitral regurgitation.

    Recruiting Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT06547788

  • Observational registry for patients treated with the NeoChord Artificial Chordae System

    This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.

    Recruiting at 5 sites NeoChord · Bonn and 4 other locations · NCT04190602

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.